Oral Supplementation With a Formulation Based on Cetylated Fatty Acids for Post-fracture Long Bone Healing

Randomized, Double-blind, Placebo-controlled Study With 12 Weeks Oral Supplementation With a Formulation Based on Cetylated Fatty Acids to Support the Early Stage of Long Lower Limb Bone Healing After Fracture Stabilization

This clinical study aims to evaluate the potential benefits of a formulation based on Cetylated Fatty Acids in improving fracture healing of long bones in the lower limbs. The investigational product is administered orally over a 12-week period. Study procedures are limited to standard imaging techniques (radiography and echography), blood sampling, and completion of validated quality of life questionnaires.

Inclusion Criteria:

• Between 18 and 85 years old
• Presence of simple closed unifocal fracture (transverse, oblique, spiral, butterfly-shaped) in a long bone which need a standard of care surgical stabilization
• Presence of diaphyseal fracture of lower limb (femur or tibia, Subtrochanteric fracture are also allowed)
• Presence intramedullary nail
• Weight bearing as tolerated after surgery
• Having signed an informed consent, understand study procedures and ability to follow them
• Agreed to stop vitamin D intake for participants who take prophylactic Vitamin D

Exclusion Criteria:

• Treatment with vitamin D for medical purpose (Non-union, osteoporosis…)
• BMI > 30
• Open fracture
• Intra articular fracture
• Metaphyseal fracture
• Polytrauma patient (injury severity score: ISS >= 16)
• More than one lower limb long bone fracture
• Bridging plate
• Fracture treated conservatively with plaster
• Presence of active infection (body temperature ≥ 38°C or other symptoms)
• Any sign of severe vascular compromise across the fracture site (such as compartment syndrome, presence of serious vascular damage, etc.)
• Pathological fracture or diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
• Participants with known bone disease which would negatively impact on the bone healing process
• Participants currently being treated with radiation, chemotherapy, immunosuppression, or steroid therapy
• Diabetic participants
• Daily smoker participants (cigarette or vaping containing nicotine)
• Participants under cortisone intake
• Participants under rheumatic medications intake
• Allergy or adverse effect of food supplement composition
• Unwilling or unable to take study medication
• Chronic drug or alcohol abuse
• Pregnant or breastfeeding at the time of enrolment
• Any other investigational treatment or food supplement within 3 months.